Manufacturing Support Specialist III

Responsibilities

• Perform aseptic processing of in-house solutions according to cGMP guidelines
• Oversee cleaning and sanitization of GMP areas and manufacturing equipment
• Review, revise, and update SOPs, batch records, and manufacturing documents
• Mentor and train new staff on manufacturing processes and safety protocols
• Manage inventory through routine cycle counts and ERP system transactions
• Assist in deviation and CAPA investigations to identify root causes
• Collaborate with quality assurance and engineering teams to ensure seamless operations

Requirements

• AS/BS in Biotechnology, Biology, Chemistry, or a related science field
• 2-4 years of experience in biotechnology manufacturing or GMP environments
• Demonstrated expertise in aseptic techniques and GMP cleaning
• Strong knowledge of cGMP and GDP standards
• Proficiency in Microsoft Office and ERP systems
• Ability to stand for extended periods and wear protective clothing

Preferred Qualifications

• Certification in aseptic techniques or GMP training
• Experience with SOP revision and documentation control
• Experience with deviation/CAPA investigations

About the Company

ProKidney is a biotechnology company focused on advancing cell therapies to treat kidney disease.